Kornimate/medical-research-clean huggingface dataset:
a study of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with her2-positive metastatic breast cancer (pherexa)

Conditions: Breast Cancer

Summary: this randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer. the study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. all patients in arm a and arm b received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in arm a and 1000 mg/m2 twice daily in arm b). in addition, patients in arm b received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. study treatment continued until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * adult female patients \>/=18 years of age * metastatic her2 positive breast cancer * eastern cooperative oncology group (ecog) performance status 0 or 1 * disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen) * prior treatment with taxane-containing regimen * left ventricular ejection fraction (lvef) \>/=50 percent * for women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment exclusion criteria: * prior treatment with pertuzumab or capecitabine * concurrent treatment with other experimental drug * concurrent immunotherapy or anticancer hormonal therapy * serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease) * central nervous system (cns) metastases, which are not well controlled * history of exposure to anthracycline cumulative dose equivalent to 360mg/m2 * history of congestive heart failure of any new york heart association criteria, or serious cardiac arrhythmia requiring treatment * history of myocardial infarction within 6 months prior to randomization * history of lvef decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab * history of another cancer which could affect compliance or result interpretation * inadequate organ function * pregnant or breastfeeding women * life expectancy \< 12 weeks
the efficacy of surgical treatment after neoadjuvant chemotherapy plus intraperitoneal immunotherapy versus chemotherapy alone for patients with positive wash cytology gastric cancer

Conditions: Gastric Cancer, Metastatic

Summary: the purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.


Eligibility criteria:
inclusion criteria: * ecog 0-2 * histologically proven gastric cancer t2-3 n+, t4a with any n (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (tnm classification 7th edition) * histological forms: gastric adenocarcinoma and signet ring cancer * blood characteristics (creatinine \ 90 g/l, thrombocytes \> 100000/mkl) exclusion criteria: * clinically apparent distant metastasis (besides free cancer cells) * synchronic or metachronic malignant tumors * previous systemic or surgical or combined therapy for gastric cancer * complications of gastric cancer (obstruction 0-1 gooss scale and/or gastric bleeding) * adhesions in abdominal cavity * gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.

Keywords: gastric cancer, metastatic positive wash cytology neoadjuvant intraperitoneal immunotherapy
tenon medical catamaran™ si joint fusion system ct scan study

Conditions: Sacroiliac Joint Disruption; Degenerative Sacroiliitis

Summary: the objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the catamaran si joint fusion system. in addition, retrospective and prospective clinical outcomes will be evaluated.

patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the catamaran fixation device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic ct-scan to assess fusion. additionally, retrospective clinical outcomes will be collected from the medical records.

Eligibility criteria:
inclusion criteria: * patient \>18 years of age at time of treatment with the catamaran si joint fusion system * patient implanted with the catamaran fixation device within the last 12 months * diagnosis of sacroiliac joint disruption or degenerative sacroiliitis * patient, or authorized representative, signs a written informed consent form to participate in the study * patient is willing and able to complete study follow-up requirements exclusion criteria: * known or suspected active drug or alcohol abuse * previously diagnosed osteoporosis (defined as prior t-score \<-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis. * prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture) * prior diagnosis of tumor in sacrum or ilium * unstable fracture of sacrum and or ilium involving the targeted sij * osteomalacia or other metabolic bone disease * use of medications known to have detrimental effects on bone quality and soft-tissue healing * patient is pregnant or wishes to become pregnant during the study period * patient is not likely to comply with the follow-up evaluation schedule * patient is a prisoner or a ward of the state
a comparison of two different methods to reduce intramusculer injection pain

Conditions: Healthy

Summary: when the literature is reviewed, there are few studies evaluating cold spray or shotblocker in reducing pain associated with im injection. studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. these methods are less commonly used on adults. both methods without side effects are important in terms of being cheap, easy to use and reusable. as a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain. the aim of the study is to use it to reduce pain associated with im injection in adults. to evaluate the effect of cold spray and shotblocker applications on pain.

when the literature is reviewed, there are few studies evaluating cold spray or shotblocker in reducing pain associated with im injection. studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. these methods are less commonly used on adults. both methods without side effects are important in terms of being cheap, easy to use and reusable. as a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain. the aim of the study is to use it to reduce pain associated with im injection in adults. to evaluate the effect of cold spray and shotblocker applications on pain. in this study, it was used to reduce pain associated with im injection in adults. it was aimed to evaluate the effect of shotblocker and cold spray application on pain. the research is planned to be completed between february 2020 and december 2020. the universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in malatya turgut özal medical center emergency service. 195 patients selected by the simple random sampling method (shotblocker group = 39, shotblocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. participant introduction form and visual benchmarking scale (vas) were used to collect data. according to the characteristics of the data in independent groups, t test, anova test, mann whitney u test, correlation were measured.

Eligibility criteria:
inclusion criteria: * being 18 years or older * communication, * having no problems with vision and hearing, * no pain, scar tissue, incision, lipodystrophy and signs of infection in the application area, * body mass index between 18.5 and 30, * there is no history of allergy. exclusion criteria: -

Keywords: intramuscular injection pain cold spray shotblocker
efficacy of oral corticosteroid therapy in recurrent paralyzes after thyroidectomy

Conditions: Recurrent Paralysis of Vocal Cords

Summary: thyroidectomy is a common surgical procedure in france. recurrent paralysis is one of the main complications. oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible. the main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.


Eligibility criteria:
inclusion criteria: * patients scheduled for simple total thyroidectomy or lobo-isthmectomy * patients over eighteen years old * free subject, whitout tutorship or curatorship or subordination * informed consent and signed by the patient after clear and fair information about the study. exclusion criteria: * patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology * patients with preoperative recurrent paralysis * patients with hypersensitivity to prednisolone or any of the excipients. * patients with contraindication to use solupred * patients with anti-inflammatory of acetylsalicylic acid * patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
crestor athero imaging head to head ivus study

Conditions: Coronary Atherosclerosis

Summary: a 104-week, randomized, double-blind, parallel group, multi-center phase iiib study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.


Eligibility criteria:
inclusion criteria: * clinical indication for coronary angiography * angiographic evidence of coronary artery disease (cad), as defined by at least 1 lesion in a native coronary artery that has \>20% reduction in lumen diameter by visual estimation * left main coronary artery must have \<=50% reduction in lumen diameter by visual estimation * ldl-c \>100 mg/dl (2.6 mmol/l) for patients with no statin therapy in the past 4 weeks; ldl-c \>80mg/dl (2.08mmol/l) for patients on therapy in the past 4 weeks exclusion criteria: * use of certain lipid-lowering medication for more than 3 months within the previous 12 months. longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. * patients who have symptoms consistent with moderate or greater severity of congestive heart failure (chf). * clinically significant heart disease which, in the opinion of the principal investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study

Keywords: coronary artery disease
gene-guided warfarin for anticoagulation therapy

Conditions: Stroke

Summary: this study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of inr value. it will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients) * clinicians judge that long-term oral anticoagulation with warfarin is required * no anticoagulation treatment in the past 10 days * agree to participate in this project exclusion criteria: * patients who had a tendency to bleed when taking warfarin * high-risk groups using warfarin anticoagulation
assessment of the number of missing tooth surfaces and the molecular findings on the outcomes of vital pulp therapy using two calcium silicate materials

Conditions: Vital Pulp Therapies; Tooth Defect

Summary: the present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to: a. number of tooth surfaces defects: * class i cavity defect. * class ii cavity defect. b. using two types of pulpotomy dressing materials: * mta+ (cerkamed, stalowa, poland). * well-root pt (vericom, gangwon-do, korea). and., to correlate this outcome to the quantification of two biomolecules: * tumor necrosis factor-alpha (tnf-⍺). * matrix metalloproteinases-9 (mmp-9). based on the results of the present study, it was concluded that: 1. full pulpotomy using calcium silicate cements (cscs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis. 2. class i and class ii cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials. 3. although mta+ and well-root pt yielded similar outcomes for pulpotomy in terms of success rates. well-root pt is easier to handle compared to mta+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with mta+. 4. neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome. 5. the concentration of tnf-α and mmp-9 biomarkers directly impact the outcome of pulpotomy.

the current study addresses an important gap in research, as the impact of cavity configuration on the outcomes of full pulpotomy has not been well explored. comparing class i and class ii cavity defects in this context can provide valuable insights, especially given the differences in structural integrity, bacterial infiltration risks, and restorative challenges associated with these defects.

Eligibility criteria:
inclusion criteria: * mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis. * age range of 21-45 years old. * males or females. * no disabilities. * class i and/or class ii cavity defects. * teeth reveal positive response to cold tests. exclusion criteria: * presence of open apices. * non-restorable teeth. * teeth in which the pulpal bleeding time is more than 10 minutes. * presence of large carious lesions approaching the root. * presence of calcification or resorption. * periodontally affected teeth. * patients who are taking antibiotics within one week before treatment. * patients consumed taking analgesics within 24 hours before treatment. * systemically compromised patients. * pregnant females.

Keywords: biomarkers calcium silicate cements full pulpotomy irreversible pulpitis mature teeth
effect of combination of mitiglinide and metformin on glycemic control in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: we performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. subjects with hba1c \>7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (met+mit) or metformin plus placebo (met).

this was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (met+mit) versus metformin plus placebo (met+pcb). an 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). the subjects with an hba1c \>7.0% at the end of the metformin run-in phase were randomized to a met+mit group or a met+pcb group of the trial phase.

Eligibility criteria:
inclusion criteria: * aged 30-70 years * had a duration of diabetes of \<10 years * body mass index (bmi) 20-35 kg/m2 * a plasma hba1c level of 7.5-11% during the previous 4 weeks exclusion criteria: * subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes * subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks
open-lable extension study on safety and efficacy of neramexane to treat congenital and acquired nystagmus

Conditions: Nystagmus, Congenital; Nystagmus, Acquired; Multiple Sclerosis

Summary: the purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (cin). in addition, a subgroup of multiple sclerosis (ms) patients suffering from acquired nystagmus will be included.


Eligibility criteria:
inclusion criteria: * patients who has succesfully completed the lead-in study mrz 92579-0707/1 exclusion criteria: * occurence of any major treatment-emergent adverse event or condition during the previous protocol (mrz 92579-0707/1)

Keywords: nystagmus, congenital idiopathic
remote myocardial ischemic preconditioning in humans

Conditions: Coronary Artery Ischemia

Summary: ischemic preconditioning (ip) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. our primary hypothesis is that remote ip reduces myocardial ischemic injury during pci.

our primary hypothesis is that remote ip reduces myocardial ischemic injury during pci. we will also test the hypotheses that ip diminishes the inflammatory response to pci, and that higher baseline blood endothelial progenitor cell counts are predictive of a favorable response to ip. aim 1: to evaluate whether remote ischemic preconditioning reduces the frequency of myonecrosis (troponin t≥0.03 ng/ml following pci). aim 2: to evaluate whether remote ischemic preconditioning reduces the inflammatory response to pci (post pci hscrp level). aim 3: to evaluate whether pre-procedure circulating endothelial progenitor cell counts correlate with the effect of remote ischemic preconditioning on myonecrosis. background: percutaneous coronary intervention (pci) frequently results in ischemic myonecrosis. ischemic preconditioning (ip) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. our primary hypothesis is that remote ip reduces myocardial ischemic injury during pci. aims: the aims of the study are to assess in patients with coronary artery disease requiring pci, whether remote ip reduces: 1) the frequency of myonecrosis; and 2) the inflammatory response to pci; and 3) whether the effect of ip correlates with pre-procedure circulating endothelial progenitor cell counts. methods: the study is a prospective, randomized trial to assess the efficacy of remote ip as adjunctive non-pharmacological therapy for pci in patients with stable or unstable angina. remote ip will be performed by 3 cycles of 3-minutes of arm ischemia alternating with 3- minutes of reperfusion of the arm immediately before pci. myonecrosis and inflammation will be detected by measuring serum troponin t and high sensitivity c-reactive protein, respectively. blood epc counts will also be measured before the procedure.

Eligibility criteria:
inclusion criteria: * patients will be eligible for randomization if they meet the following criteria: 1. age ≥ 18 years 2. clinically indicated elective or urgent pci exclusion criteria: * patients will be ineligible for the study if one or more of the following conditions exist: 1. pre-pci troponin t ≥ 0.03 2. systemic hypotension (systolic \<90 mmhg) or cardiogenic shock 3. presence of an arteriovenous fistula or lymphedema of either arm 4. currently enrolled in other active cardiovascular investigational studies 5. severe endocrine, hepatic, renal, disorders 6. pregnancy or lactation 7. inability to provide consent 8. federal medical center inmates 9. inability or unwillingness to provide informed consent

Keywords: angioplasty, transluminal, percutaneous coronary coronary artery disease coronary occlusion
examining the relationship between acute meal intake and inflammation in children

Conditions: Obesity; Inflammation

Summary: recent evidence has shown that obese and overweight children exhibit states of chronic inflammation. in obese adults, a high carbohydrate meal induces an inflammatory response; however, the effects of a high carbohydrate meal on biomarkers of inflammation has not previously been examined in children. the purpose of this research project is to characterize the inflammatory response to a high carbohydrate versus a low carbohydrate meal in healthy weight, overweight, and obese children (age 7-17 years). after completing informed consent/assent, a dual-energy x-ray absorptiometry (dxa) scan, and baseline blood draw on experimental day 1, children will then return to the lab two times to ingest either a high or low carbohydrate beverage followed by post-meal blood collection for a total of 3 blood draws. biomarkers of inflammation will be analyzed by flow cytometry and enzyme-linked immunosorbent assay (elisa). participants will be recruited through various studies through the neurocognitive kinesiology lab/body composition and nutritional neuroscience labs as well as through the local champaign-urbana community. data from this project will provide a better understanding of the inflammatory response to different meals in healthy weight, overweight, and obese children.


Eligibility criteria:
inclusion criteria: • between the ages of 7-17 exclusion criteria: * younger than 7 years and older than 17 years * presence of allergies to eggs and/or sugar substitutes * presence of heart or respiratory disease * presence of uncontrolled hypertension, diabetes * use of anti-inflammatory medications * presence of cancer or metabolic disease

Keywords: children inflammation obesity